Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With ER/PR Positive Early Breast Cancer Who Are Using Adjuvant Letrozole
Phase 3
- Conditions
- Cancer
- Registration Number
- PACTR202112813934276
- Lead Sponsor
- AUH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
1- Histologic evidence of ER/PR positive breast adenocarcinoma
2- Postmenopausal women.
3- Baseline LS and total hip BMD T-score > -2.0.
4- No prior treatment with denosumab or IV bisphosphonates is allowed.
5- No prior treatment with radiopharmaceuticals.
6- Not pregnant and not nursing.
7- Good dental health.
8- ECOG performance status 0-2.
9- Calculated creatinine clearance >= 30 mL/min.
10- Corrected serum calcium >= 8.0 mg/dL (2.00 mmol/L) and < 11.6 mg/dL (2.90 mmol/L)
Exclusion Criteria
1- Patients with dental problems.
2- Patients with impaired renal functions
3- Patients with osteopenia, or T- score is below -2.0
4- Patients with history of serious drug hypersensitivity or drug allergy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be the percentage change in lumber spine (L2-L4) BMD at 12 months for immediate- versus delayed-ZOL patients.
- Secondary Outcome Measures
Name Time Method Secondary end points will include percentage change in total hip BMD at each assessment, fracture incidence, time to disease recurrence (local relapse or distant metastasis), DFS, and safety.